The Food and Drug Administration (FDA) will soon require researchers conducting late-stage clinical trials to outline their plan for ensuring racial diversity among trial participants.
Last year, a report
published by the U.S. National Academies of Sciences, Engineering, and
Medicine concluded that efforts to ensure that trials are more radically
and ethnically diverse had "largely stalled."
- Older adults, disabled individuals, and pregnant women are typically under-represented in clinical trial pools.
- Recent
studies found that only 11% of FDA trials between 2012 and 2017 had
numbers of participating ethnic and racial minorities that were
proportionate to their percentage of the broader U.S. population.
- The new diversity rule
will require researchers and the pharmaceutical firms they work with to
outline their demographic goals and how they plan to meet them.
- The rule was enacted as part of the spending bill signed by President Joe Biden last December.
- The
FDA will need to finalize its draft guidance and offer a public comment
period before the rules are fully implemented — a process that could
take more than two years.
- It is unclear how the FDA
will enforce the rule, which will permit some exemptions for public
health emergencies and research on diseases that are not found across
the general population.
